June 2006
Blogs Don't Matter
Except to the Clinton campaign, and two other potential presidential candidates, the first having hired a blogger on staff today and the latter two having given speeches at a "bloggers convention."-Sean Philpott
Cleveland Clinic: The Natural Place to Hold a Conference on Conflict of Interest in Innovation. Not.
I love Cleveland Clinic. I've made no secret about it. I'd be working there now had I been able to persuade my wife that Cleveland is the center of the universe.
So it was no fun to tear into them over the preposterous problems the institution has created for itself with the appointment and continuation of a board of directors riddled with conflict of interest, with its summary execution of Eric Topol, or with the odd way in which the institution has handled Toby Cosgrove's conflicts of interest with his devices and their trials at the Clinic. But I'm all done feeling bad. The CCF has crossed all sorts of lines with its Karl Rove-worthy, no-ethics-left-behind conference on "conflicts of interest in innovation," featuring for example a section on "Guidelines and Performance: Creating a Culture of Ethics." The conference itself is just lovely, featuring a litany of the extraordinarily powerful including a whole bunch of pharma top brass, and one ethicist, Jeff Kahn, who will really have to shine in the three panels on which he serves in order to help this institution hold this conference with a straight face: there isn't a single mention - not one - of the issues the Clinic has created for all of medicine and for itself with its abominable and unethical treatment of Topol in the Vioxx matter, with its mishandling of the Cosgrove devices, and with its board of directors, more than half of whom (according to Wall Street Journal) do business with the Clinic.
The chutzpah. Imagine Penn holding a conference a year after the death of Jesse Gelsinger on how to do gene therapy well - without mentioning Gelsinger in the program. Or Johns Hopkins holding a conference on how to set up clinical trials with children and lead paint without highlighting the Kennedy Krieger lead paint study. No, really, this is worse than that. This is like Anderson Consulting holding a conference on how to handle the disposal of paperwork for oil companies.
The irony is that, as we discuss in our article, Eric Topol of the Clinic did perhaps the best job of learning from a problem in conflict of interest in the history of medicine. He too went very public, conducting study of the phenomenon of physician involvement in hedge funds and similar activity. He was very candid about his own encounter with a little hedge fund, surveyed to find that lots and lots and lots of physicians offer similar advice or other information in inappropriate ways, and then Topol offered some suggestions about how to prevent the problem in the future. He discussed the problem self-referentially, rather than trying to confuse people into thinking he'd never had an issue in the area by holding a big conference in which he didn't mention his own misadventures.
But he's gone now, down the street to Case Western Reserve, after he was fired from two of his positions and removed by extension from the ... yes ... conflict of interest committee, after testifying against ... yes ... Merck (that's right, the same Merck whose former CEO will be on the program) on the Vioxx matter.
It's big entertainment, I'll give them that. But seriously - this is a mockery of bioethics. And that they charge $300 for this ... why not just ask one of the board members' companies to subsidize the $300 ... then again, wouldn't want to create a confli...
You get the point.
Being Provigilant About Enhancing the Brain
A Dose Of Genius, says the Washington Post of the "new smart pills." They are here to stay. Ushered in by college kids who understand the implications of cognitive enhancement for their future, drugs like Provigil are taking off and with them performance:Seen by some ambitious students as the winner's edge -- the difference between a 3.8 average and a 4.0, maybe their ticket to Harvard Law ... they are often obtained free from friends with legitimate prescriptions, students report ... These drugs represent only the first primitive, halting generation of cognitive enhancers. Memory drugs will soon make it to market if human clinical trials continue successfully.Where are the cops to catch these guys?
There are lots of the first-generation drugs around. Total sales have increased by more than 300 percent in only four years, topping $3.6 billion last year, according to IMS Health, a pharmaceutical information company. They include Adderall, which was originally aimed at people with attention-deficit disorder, and Provigil, which was aimed at narcoleptics, who fall asleep uncontrollably. In the healthy, this class of drugs variously aids concentration, alertness, focus, short-term memory and wakefulness -- useful qualities in students working on complex term papers and pulling all-nighters before exams. Adderall sales are up 3,135.6 percent over the same period. Provigil is up 359.7 percent.
This is not "the type of data collected by the FDA," he says. Law-enforcement activity has been sparse. "Who is the complainant?"Plus just think about it: a smart drug that helps keep you from being sleepy, that you activate by looking at light. Just listen to this testimony. The only problem is that people are supposed to sleep eventually.
Compared with the kind of drug users who get police attention, "This is an entirely different population of people -- from the unmotivated to the super-motivated," Restak says. These "drug users may be at the top of the class, instead of the ones hanging around the corners."Smart-pill use generally doesn't show up in campus health center reports, he says, because "This is not the kind of stuff that you would overdose on" easily. Amphetamines are associated with addiction and bodily damage, but in use by ambitious students, "if you go a little over you get wired up but it wears off in a couple of hours. And Provigil has a pretty good safety record." Finally, smart-pill use is a relatively recent development that has not yet achieved widespread attention, much less study, although Restak expects that to change.
"We're going to see it not only in schools, but in businesses, especially where mental endurance matters." Restak can easily imagine a boss saying, " 'You've been here 14 hours; could you do another six?' It's a very competitive world out there, and this gives people an edge."
Prolife Blogs Predicts "Bioethics Rumble in Albany"
ProLifeBlogs, read by who knows how many billion out there
"he joins a bioethics conference in Albany along with Nigel Cameron who has written a bioethics column for Christianity Today. Wesley has predicted some 'respectful fireworks', which will be good because right-to-die-friendly bioethicist Art Caplan will be there. Art recently eulogized Dr Ron Cranford in the most glowing of terms." Well we can't have that. Cranford certainly shouldn't have been mourned by those who agree with him. Those darn liberals, with their respect for the dead. Don't they get it that there are 8 cell embryos crying out from freezers everywhere!
[rumble. rumble. rumble rumble.]
There are about 30 second left to register for this conference - in fact we may be 150% at this point - but if enough request it we will try to accommodate a second Crowne Plaza room for the Pellegrino lecture. After that, it really comes down to fire code and room availability.
The Crowne Plaza is sold out. The next best thing is the Morgan State House, but when it fills try the 3 month old Hampton Suites downtown, home of Yono's, one of the better downtown Albany restaurants to open in the past 6 months, though my favorites in that category would be Blue 82 and Noche, both sort of tapas/bar places. For more information on the conference though contact Albany Med at 518.262.5828.
The Link Between MMR and Autism Produced by Misconduct
Independent reports that:The doctor who sparked an international scare over the safety of MMR vaccine is to be charged with serious professional misconduct by the General Medical Council in an attempt by the medical establishment finally to lay the controversy to rest.
Andrew Wakefield, who published a research paper in 1998 purporting to show a link between the MMR vaccine and autism, is accused in preliminary charges of publishing "inadequately founded" research, failing to obtain ethical committee approval, obtaining funding "improperly" and of subjecting children to "unnecessary and invasive investigations", The Independent has learnt. The research is said to have caused immunisation rates to slump and cases of measles, mumps and rubella to soar. The research, which appeared in The Lancet, is said to have done more damage than anything published in a scientific journal in living memory.
Northfield Goes on Record on Polyheme Issues
The current issue of AJOB is making news daily, as one community after another asks questions about research where there is no possibility for informed consent (in many cases). Everyone wants to know why community consultation for resuscitation research seems to be so difficult, and why in the absence evidence of good community notification, IRBs let studies proceed. AJOB devotes an entire issue (the first ever in bioethics) to the issue, and it is filled with commentaries and articles that constitute a cookbook for sponsors of these trials, in the vague hope (in many authors' minds) that sponsors will be able to emerge from a kind of weird denial in order to save themselves from the PR catastrophes they continue to create for themselves.
You'd think that Northfield Labs (the sponsor/owner of PolyHeme) would have something thoughtful to say about how that company, in the middle of a tornado, will be dealing with the matter, particularly when the company representative is being interviewed for an article by Gannett News Service that ran not only in USA Today but in dozens of other papers about the matter.
Nope, he proposed nothing, no committee, no ethics team, no refinement of materials, and still no answers of consequence to the charge made by Penn researchers and later by Johns Hopkins itself, that there was a coverup of material that should have been published. No comment of consequence even when the Johns Hopkins researcher the company had said would clear everything up was subsequently denied - just a few months ago - the data he needed to give that speech.
You'd think Northfield would want, in the face of all this controversy, to resolve any doubts that might otherwise need to be shared with the community. But instead the company seems to have a zero ethics plan:
“Is this a good reg? Is it perfect? Can it be better? Can it be worse? Those are important policy questions that we feel we can and should address,” says Steven Gould, chief executive of Northfield Laboratories, the firm that makes and is studying PolyHeme. “To do research without prospective informed consent defies what we would all say is good ethical practices, so you have this conundrum.”Yes. So you will be doing what? Asked by this journal to respond to the King article, Northfield refused. Asked to participate in a discussion with PIs of the trial about how to refine community consultation so that communities can understand the ongoing issues that are in articles like this one, the company offered to consider the idea then didn't reply. Asked whether they would like to try to convene an ethics review, board, study or to participate in any other review of the associated issues with others, there was no reply.
The conundrum is there, no question. But it isn't about the ethics of research without informed consent, or about their failure to respond adequately (in the minds of many) to charges that their study is designed so that it intentionally requires that subjects receive Polyheme instead of blood even after they arrive in hospitals (and without consent), contrary to the standard of care.
No, the the conundrum is how Northfield will manage to avoid killing off resuscitation research entirely, while sitting in wait for a Senator who is mad as hops. Somebody please wake these guys up.
[update]Or on the other hand, if the greed boys have it right, none of this will matter and within days there will be Polyheme in every healthcare facility in the nation. Ah, markets.
Selling Eggs: A True Story
You really want to read Golden Eggs, the first-of-its-kind story in the Boston Globe about the experiences of an egg donor. It isn't the first narrative, in fact there have been books and series and TV programs. But this is Pulitzer stuff:
JAMIE GALBRAITH SITS SLIGHTLY HUNCHED OVER AT JAKE'S, THE RESTAURANT in a Marriott hotel in Woburn. She's uncomfortable, and she hasn't eaten much, because yesterday morning she spent 45 minutes in stirrups at the Brigham and Women's Hospital Center for Assisted Reproduction while a doctor suctioned 66 eggs out of her ovariesA little cramping is a small price, Galbraith tells me, considering that a Boston couple is paying her $15,000 for her trouble. She is 5-foot-8 and has green eyes and naturally blond hair. She lives in Michigan, but human eggs don't stand up to shipping, so she came to Massachusetts and to her clients' fertility clinic for the operation. This is her fourth procedure in three years; she has another scheduled in July in New Jersey.
It would be nice to say that she is only here to help someone. That this mother of two and military wife wants to spread the joy of family life - and she does. But there's another reason why Galbraith, who turns 27 this week, has spent so much time in stirrups. She needed to raise a down payment for a house and relieve some of the $14,000 in loans she's using to pay the University of Phoenix online, where she is studying for a bachelor's degree in business.
Galbraith's fee is on the high end of the spectrum, which starts at about $5,000 per donation cycle. That's the process by which eggs are artificially stimulated to mature, then surgically "harvested," or extracted. Prospective clients are shown pictures of Galbraith now, as a baby, and during adolescence. They also see photographs of her children, now 6 and 9. But what sells even more persuasively is her track record. Each of her three prior donations produced egg counts in the 40s - more than double what is typical - and each resulted in offspring. So her price has climbed, from $5,000 to $8,000 to $15,000.
What's more, she and her sister, a nursing student in Illinois who is also a donor, are starting their own agency to recruit other donors and match them with patients. The sisters have already recruited a few of their friends and are actively looking for more donors.
Vanessa Gamble, Director of the Tuskegee Bioethics Program
In the West Philly Spotlight
Vanessa Gamble, director of the Tuskegee bieothics program essentially endowed as part of President Clinton's apology for the Tuskegee Experiment, is 'still a girl from West Philadelphia and I will never let anyone forget it,' Gamble told the 54 graduates of Hamilton's Academics in Middle School program yesterday." Philadelphia Daily News follows her as she talks about her roots, her goals and her life:She said was only 6 years old when she decided to become a doctor. To this day, she said, she doesn't know how she got the idea.But her mother and grandmother, who raised her after her parents separated, believed in her.
She got chemistry sets and microscopes for toys.
She talked of how her grandmother once got upset with a neighbor who didn't believe that the young Gamble would become a doctor someday.
"She said, 'Right.' And my grandmother said, 'Just wait.' "
Gamble told the graduates, many of them superachievers themselves, never to allow other people to keep them from their goals.
"Don't let anyone say you can't do something," she said. "Life won't be easy, but you have the skills to make it."
Gamble, 53, earned both her medical degree and her Ph.D. from the University of Pennsylvania.
She surprised the audience by announcing that she planned to present an annual award "to a member of the Hamilton graduation class who has achieved greatly in the face of adversity."
Calling China. Please, Would You Mind Sharing Information on Epidemics a Little Bit Faster? We Call That Ethics
A couple of days ago, the New England Journal of Medicine announced that it had accepted an article from eight Chinese scientists reporting that, upon retesting, a man initially thought to have died from SARS during the 2003 epidemic actually succumbed to avian flu (H5N1). If confirmed, this case would represent the earliest reported case of human bird flu infection on the Chinese mainland, approximately two years before the first official Chinese case of H5N1. Shortly after the issue had already gone to press, however, the lead author had reportedly sent several emails to the Journal asking that the manuscript be withdrawn. In a Hitchcockian (or perhaps Orwellian) twist, the New York Times reveals that the request to withdraw the paper now appears bogus. The important question now is whether or not Chinese officials were directly involved. If so, they clearly have not heeded the lessons of 2003 when the public health community was outraged to learn the Chinese government hid dozens of SARS-related deaths with its months-long public denial of the epidemic. When millions or even billions of lives are at stake, public health should not be treated like a playground insult: “Nyah nyah! Your country has avian flu.” “Does not.” “Does too.”
- Sean Philpott, PhD, MS Bioethics, new Associate Director of AMBI
State Bioethics by Jim Fossett:
Abortion in the Fifty States
The most recent issue of Stateline.org, an on-line magazine that covers state government and politics, contains an excellent article on the legal status of abortion across the fifty states. The overwhelming focus on whether the newly constituted Supreme Court will overturn or modify Roe v. Wade doesn’t pay enough attention to the fact that state actions will be more influential in determining womens’ access to abortion than anything the Supreme Court does. Even inside the Roe framework, the accessibility of abortion varies enormously across the states. In larger, more urbanized states; access to abortion providers is better. Fewer than 10 percent of the women in California, New York, Connecticut, Massachusetts, and New Jersey live in a county without an abortion provider. By contrast, 75 percent of the women in smaller rural states such as West Virginia, Mississippi, and Wyoming have to travel to another county. Some states have gone to considerable trouble to make abortions as difficult to get as possible while staying inside the Roe framework. In others, the right of a woman to terminate a pregnancy has been held to be constitutionally protected.
The point is clear---Changes to Roe v. Wade are only the first step, and maybe not the most important one, in changing access to abortion. What does, or doesn’t, happen in state capitals is likely to have more far wide reaching consequences. James Fossett, Director of the Bioethics and State Policy program of Rockefeller Institute of Government and AMBI
Go Team Viagra. And Afterwards, the Sex.
From Chicago Trib:Researchers reported Thursday that cyclists may be able to increase their performance by taking Viagra--their athletic performance, that is.
Some cyclists have more trouble than others in sustaining high levels of exertion at mountainous elevations. The new study found that Viagra, a drug most commonly used to treat male impotence, helped overcome that problem.-Sean Philpott
For these cyclists, taking Viagra improved their performance up to 45 percent, which would allow a cyclist racing in the high Rocky Mountains to cover a stretch of road in 39 minutes that would otherwise take an hour.
The findings, published in the Journal of Applied Physiology, come at a time when competitive cycling has been struggling to prevent athletes from using banned drugs and other methods of bolstering performance. Viagra is not currently among the blacklisted drugs.
Making an Impact
Without fail and every year, the Institute for Scientific Information ranks the major journals of science and medicine by calculating an Impact Factor for every journal whose citation rates it has tracked for more than three years. The Impact Factor is derived by determining how often articles in the tiny minority of journals covered by ISI are cited. The top journals aren't hard to identify, just ask any dean of medicine or science or engineering or even liberal arts; the Impact Factor of publications for any prospective hiree or candidate for tenure in the social and natural sciences is discussed with ubiquity and perhaps to a fault, replacing perhaps subtle intuitions about which journals would be the "right" place to publish particular research, with mathematical calculations about what happens when you in fact publish taht research in Journal X. So impact Factor has become a very intimidating number for junior scholars because they have to defend to their deans why they'd publish their research about bioethics in the Journal of Medical Ethics rather than Millbank Quarterly or JAMA, or their article about ethical issues in distribution of scarce resources in AJOB rather than Health Economics.
The 2006 publication of Impact Factors by ISI is the first year that The American Journal of Bioethics has been ranked, and although we knew from many of our authors that their articles were receiving more citations than they had expected, we did not expect what ISI found: AJOB is not only the first bioethics journal with an Impact Factor to break 2.0, it also ranks ahead of many journals that we, at least, would have guessed would be far more oft cited and read in the health sciences more generally, e.g. Academic Medicine.
One very important fact to keep in mind - the Impact Factor does not include citations to articles that occur in the same journal in the same year, so for example citations to target articles in AJOB made by open peer commentary authors do not count toward the Impact Factor. Citations of articles within a year after they are published is called Immediacy Index, and there of course the AJOB system conveys a huge advantage in that so many open peer commentary authors cite the target article on which they comment, then go on to cite the whole mess in their other work elsewhere during that year. So our Immediacy Index is more than an order of magnitude above other journals in our category. But Impact Factor excluses all those internal citations. It is an apples to apples comparison of journals in the general area of bioethics and health services research. Congrats to our authors, editors, assistants, and to Taylor & Francis on this recognition of AJOB - and thanks to all of you who read AJOB this year and thought of it as important enough to cite.
Calling Carl Elliot
The Scientist tracks the increasing attention companies are paying to involving discussion of ethics in their work.South Dakota Leads the Nation?
Cynthia Gorney has an excellent piece in the June 26 issue of the New Yorker about the politics of the recently enacted South Dakota ban on abortion. The South Dakota legislation is an absolute ban--no rape-and-incest exceptions, in fact no exceptions at all except when neccessary to prevent the mother's eminent death. This legislation has been controversial among pro-life groups--the National Right to Life Committee and Americans United for Life actively opposed it, and many pro-life advocates appear uncertain that an absolute ban is a good or saleable idea. Pro-choice forces appear to have collected enough signatures to subject the measure to a popular vote in the November elections. Even pro-life voters may be uneasy with a ban that says there are absolutely no circumstances, ever, under which an abortion is justified, and pushing such voters to support an absolute ban may well backfire.
Both pro-choice and pro-life forces have a lot riding on the outcome of the November referendum--if such a ban can't pass in an extremely conservative state as South Dakota, it's hard to imagine that it could pass anywhere; but if the legislation is upheld, it's difficult for pro-choice forces to claim such results aren't what the people want. Only in America could the outcome of an election in such a small state--South Dakota's population is only about 775,000--have so many moral and political consequences for the rest of the country.
- Jim Fossett
Bioethics and Armed Conflict
Now here is a cool book that could not be more timely. Bioethics and Armed Conflict isthe first comprehensive study of medical ethics in conventional, unconventional, and low-intensity war. Michael Gross examines the dilemmas that arise when bioethical principles clash with military necessity--when physicians try to save lives during an endeavor dedicated to taking them--and describes both the conflicts and congruencies of military and medical ethics.
Gross describes how the principles of contemporary just war, unlike those of medical ethics, often go beyond the welfare of the individual to consider the collective interests of combatants and noncombatants and the general interests of the state. Military necessity plays havoc with such patients' rights as the right to life, the right to medical care, informed consent, confidentiality, and the right to die. The principles of triage in battle conditions dictate not need-based treatment but the distribution of resources that will return the greatest number of soldiers to active duty. And unconventional warfare, including current "wars" on terrorism, challenges the traditional concept of medical neutrality as physicians who have sworn to "do no harm" are called upon to lend their expertise to "interrogational" torture or to the development of biological or chemical weapons. Difficult dilemmas inevitably arise during armed conflict, and medicine, Gross concludes, is not above the fray. Medical ethics in time of war cannot be identical to medical ethics in peacetime.
A Preview of the Politics and Bioethics Conference?
Jonathan Moreno and Sam Berger square off against Eric Cohen on the question of facts about stem cell lines, disputing in particular Cohen's reading of several studies that bear on those facts. Alta calls it a smack down, but for National Review this is actually pretty tame, and the ultimate question as to whether federal policy on this matter would make any difference at all remains unanswered in the debate about whether Okarma or Thomson believe that the Bush cells are contaminated beyond use. Seriously, does it matter? The moral argument that led to limiting research to these particular cell lines is silly, and more important the availability of more cell lines from the federal government will happen when pigs fly. Want new cell lines? Go to Massachusetts.
Oddly, New York Refused to Fund Electric Shock Therapy for Autistic Children
This one is incredible to me. New York, easily the state spending the most on treating children with autism and other spectrum disorders, cut off the $50 million it was paying a school in Canton Mass for about 150 children because the school uses backpacks to shock the children with "bee sting"-like electric jolts when they misbehave:The Rotenberg Center provides an intensive, 24-hour program that begins with a typical school setting, but about half the residents require the "aversive therapy" of electric shock, according to Rotenberg staff. The center describes the one- to two-second shocks as similar to a bee sting.What's next? Defunding a lobotomy clinic for autistic kids in Maine?For years, the state has contracted with the facility, where autistic and other disabled students wear backpack-like devices that shock them when they misbehave.
What's the Big Deal? I Mean, It's Only $585,000!
Rick Weiss reports on the hearings at which NIH geriatric psychiatry chief for the NIMH Trey Sunderland is being skewered:A world-renowned Alzheimer's disease researcher at the National Institutes of Health took advantage of the agency's lax oversight by improperly forwarding valuable tissue specimens to a pharmaceutical company and then accepting hundreds of thousands of dollars in consulting fees from it, according to congressional investigators.
Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, failed to tell agency officials about his arrangement with the drug giant Pfizer Inc., as required by federal rules, the investigators concluded in a 27-page preliminary report released yesterday.
Sunderland also did not properly disclose arrangements with another company, said the report, which found no wrongdoing by the drug companies. And though the NIH has not released the findings of its own investigation, the House report said the agency has concluded that Sunderland committed "serious misconduct, in violation of HHS ethics rules and federal law and regulation."
Cell Publishes its First Bioethics Article
For a billion years Cell has sworn they will not publish bioethics, or for that matter anything "Soft." Well, for the first time, the most powerful journal in all of science has published an article about bioethics. Our own Paul Root Wolpe authors "Reasons Scientists Avoid Thinking about Ethics" in the June 15th issue [subscription required]. It is difficult to imagine a more profound recognition of academic bioethics in the world of science than a bioethics article in Cell. Here's to you Paul.The Three Worst Places to Be a Postdoc
I do not think any short essay I have written has ever received as much response from scientists as this one for The Scientist. The basis for it was the annual list that everyone in science reads before choosing where to go after they finish their PhD, the "Best Places to Postdoc" ranking in The Scientist. A small bit of the essay is below, followed by a link to the complete piece:
... we allow our students to choose graduate programs based on location, then we push newly minted PhDs to apply for programs based entirely on raw indices of scientific productivity instead of paying attention to what their peers think. Small wonder that so many choose variants of my bottom three institutions, the McGee list of "Worst Places to Be a Postdoc":
1. Acknowledgement University-In some of this school's labs, you will find a large number of unpoliced junior faculty who believe that they need publications more than you. In others, senior faculty - who judge the productivity of those junior faculty, and whose huge grants brought prestige to the lab - are eager to disabuse you of the silly notion that their own authorship has anything whatever to do with writing. You will begin to wonder whether you should find a place on your CV for the thank-yous for all the articles on which you weren't identified.
2. The Allalone Institute-Here, the cubes are big, the hoods vent properly, the equipment is state of the art, and the lunchroom is spacious. Computers access all the resources you need, and if you break your arm there is insurance. Your principal investigator is around every couple of days, and if you ask she will answer anything you want to know about science, your career, or what and where to publish. The rest of the time, you are a monk. There is no one to talk with, nothing to do, and you find yourself curiously drawn to cupid.com during working hours. You wonder whether after you finish you will be able to explain your invisible friends to prospective employers.
3. Printnot University-Your dissertation was brilliant, so you have been welcomed into one of the most prolific labs in the world, where a dozen equally thoughtful and productive fellows all work alongside you in a cross between a think tank, a lab, and a bank. A bank? Yes, because virtually nothing you write in this lab can be published without the permission of the sponsors, who make a part of virtually everything you do possible with their intensely financed and highly protected intellectual property. You prepare yourself for a great career, just as long as it is spent working alongside the people who guided and funded your postdoctoral work...
The remainder of the piece is about the incredible problems that precipitate the bad decisions people make about where to do science training. I have received literally 50 letters from people who have horror stories about their own post-doctoral tortures, so I know now that this is just the tip of the iceberg - but it just proves how intensely important it is for students to pay attention to the impressions that previous post-docs have of the lives they lead as post-docs in any given lab under consideration. The wrong post-doc will ruin your life, or at least your career, more in science than in other areas. And that we have done nothing whatever to fix this problem is worse yet.
If you want to read the complete article it is here.
Polyheme Take 10
USATODAY.com isn't the place to find what is the dead center front page story about the ethical issues associated with the trial of Polyheme. The story is riddled with therapeutic misconception, with one of those People Magazine stories as the lead, the sort of story that reminds you that the plural of 'anecdote' is not 'data':
[subtitle:]On the brink of death, Hilary Williams couldn't consent to getting the experimental blood substitute that she believes saved her lifeAs Hilary Williams hung from her seat belt in the overturned wreckage of her truck — legs broken, colon ruptured and lung bruised — blood oozed from torn arteries and veins.
Hilary, 27, and her sister, Holly, 25, who was injured less severely in the crash, waited half an hour for medical help to arrive. By the time an air ambulance reached them at the crash site, about 45 miles south of Memphis, it was midday onMarch 15. Hilary's face was pale, her lips were blue, her faint pulse was fast, and her blood pressure was 55/0. She was in shock.
Because she was close to death, she instantly became eligible for enrollment in a controversial clinical trial. But because she was in no shape to consider the risks, the flight nurses did not have to obtain her consent before giving her an experimental blood substitute.
Within moments, fluid the color of merlot was dripping into her veins. Hilary, a singer/songwriter and the daughter of country singer Hank Williams Jr., became one of thousands of people across the nation who, while fighting for their lives over the past 10 years, unknowingly became test subjects in medical trials.
With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection.
Although the study that included Hilary Williams has brought criticism, she believes the infusion of blood substitute helped save her. “I thought I was going blind,” she says as she recovers in Nashville. “Everything was dark. My eyes were open but I couldn't see anything. I felt at peace. I kept wanting to fall asleep, but a truck driver who stopped kept telling me to wake up and to hang on.”
Ultimately the piece goes to the real issues:
The study in which Williams was enrolled is the most widespread use yet of PolyHeme. The trial has raised concern among some ethicists and alarm in Congress, where Sen. Charles Grassley, R-Iowa, chairman of the Finance Committee, is conducting an investigation.It looked like the Polyheme story had died down but it is back and with a very new spin: people are dying, it is claimed - one anecdote at a time - because they aren't receiving this blood substitute.Grassley is concerned that people who live in the 19 states where PolyHeme is being tested have had inadequate notice about the trial. The FDA requires that community input be sought in the regions around test sites. “It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential ‘guinea pig,' without providing a practical, informative warning to the public,” Grassley wrote in a letter to the FDA in February.
“This study raises significant ethical issues,” says King, who co-wrote an article in the current edition of The American Journal of Bioethics that faults the PolyHeme trial for withholding available treatments, namely blood transfusions, from patients.
In the trial, PolyHeme is appropriately given to patients without their consent in ambulances, she says, where blood is not available. But some patients, including Williams, also get the blood substitute for up to 12 hours in the hospital, where blood is available.
King says some patients who die from their injuries therefore will perish while “being denied an available treatment.” Though she favors the concept of waived-consent trials, she says PolyHeme could be tested on the battlefield or during elective surgeries in which “you could get prior consent.”
Steven Gould, chief executive of Northfield Laboratories, stands behind the PolyHeme trial. He says it is too complex to be performed on a battlefield and elective surgery is not the crisis situation best suited for the study of PolyHeme. Of King's comments, he says, “We have different points of view, but that is what this is all about.”
Amid the controversy, some cities stopped enrolling patients while the data-monitoring board reviewed preliminary findings.
Jim Coyne: Psychologists Get a Piece of the Torture Business
Writes James Coyne of the report in the Times about a Military change in strategy for who works on the military piece of interrogations:It looks like Stephen Behnke, head of Ethics for American Psychological Association has successfully used APA's lack of effective ethical prohibitions against involvement in torture to get a bigger market share of the torture business. Nice going, Dr. Behnke. Marty Seligman, Dr Positive Psychology, has provided consultations related to applying the learned helplessness framework for these efforts.
Is Bioethics Just Politics? You Have Nine Days to Decide if You Care
The meeting is called Bioethics & Politics and it is unprecedented in the history of the field. Only 9 Days Remain for early registration (a huge discount) and "21 Day Advance" fares are available for only another 8-9 days. The meeting, the official Summer Meeting of the American Society for Bioethics and the Humanities, is being held by the Alden March Bioethics Institute and The American Journal of Bioethics , in collaboration with Stanford University Center for Biomedical Ethics, the University of Pennsylvania Center for Bioethics, The Nelson A. Rockefeller =
Institute of Government, the Albany Law School Program in Health Law & Bioethics, and the University of Virginia Center for Biomedical Ethics.
After Terri Schiavo and Stem Cells, what is bioethics? One issue after another in bioethics has become a political battleground, from HPV vaccination, to restrictions on Medicaid, to objections to emergency contraception, to physician participation in torture and executions.
Maybe bioethics was always political, but some argue that it determined a presidential election in 2004. What happens when political and religious organizations start describing themselves as bioethics centers? Can bioethics survive separate journals, educational programs, commissions and researchers for the right and left wing? Or is bioethics' role in political controversy a sign of its health and influence?
Alden March Bioethics Institute (AMBI) in Albany, New York will bring together an exceptional array of scholars and others from the left and the right for a special American Society for Bioethics and the Humanities Summer Conference, in collaboration with Stanford University Center for Biomedical Ethics, the University of Pennsylvania Center for Bioethics, The Nelson A. Rockefeller Institute of Government, the Albany Law School Program in Health Law & Bioethics, the University of Virginia Center for Biomedical Ethics and The American Journal of Bioethics.
Who is Speaking?
Dinner and the John A. Balint Lecture will set the tone for the conference, given by sitting Chair of the President's Council on Bioethics Edmund Pellegrino of Georgetown University, to be followed by a dessert reception. Then Nigel Cameron, Arthur Caplan, Alta Charo, Eric Cohen, Richard Doerflinger, James Fossett, Jeffrey Kahn, Glenn McGee, David Magnus, Chris Mooney, Jonathan Moreno, Alicia Ouellette, Sean Philpott, William F. May, Wesley Smith, Bonnie Steinbock, Gerald and Paul Root Wolpe, Laurie Zoloth and more than 40 others in papers and panels from both sides of the aisle - an unbelievable line up of dozens of major figures any five of whom would make for an electric debate, including some who never shared a podium.
Join us July 13-14, 2006 at the Albany Crowne Plaza Hotel for a summit that is unprecedented in bioethics' history: left meets right, political meets academic, religious meet secular. And the politics are unpredictable. What is a neoconservative bioethicist? What is a progressive bioethicist?
How Do I Attend?
You register quickly. You can register online right here: https://ssl.perfora.net/politics.bioethics.net/registration.php. Conference attendance is strictly limited to 150. Early registration - with a significant discount - ends June 22, which is also the magic "21 day advance" date for booking flights. Special rates have been arranged with the Crowne Plaza for the evenings of the 12th-14th; call 1-800-227-6963 and mention that you are with the Albany Med conference to make hotel reservations. The hotel has free shuttle service to Albany airport.
If you email us (bloggers@bioethics.org) that you have registered, we'll also sign you up for a special free-drinks "blog people" reception to take place after the conference, assuming you every leave your house.
Albany is the U.S.' 9th cheapest city to fly into, and is well served by all major domestic carriers including Southwest. It is possible to depart on Thursday morning July 13th from most of the U.S. and arrive in time for the opening of the conference, and to depart on the Friday evening (7/14) in time to arrive in many destinations. Albany/Rensselaer Amtrak station offers constant direct train service to NYC Penn Station and direct trains to Boston and Montreal.
Any Questions?
If you have any questions about continuing education credits, discounted rates for students or groups of students or faculty, or how to enjoy the area before and after the conference, please contact Marlena Schreifels, Education Coordinator for Albany Med, at (518) 262-5828 or contact conference chairman Glenn McGee.
The Sale of Tissue Samples from NIH to Pfizer
This is a copy of the full, staff report of the House Energy and Commerce Committee on the sale of spinal cord fluid tissue samples by a scientist at the NIH to Pfizer. It makes for some pretty chilling reading. It also stands as a stark reminder that without more oversight and regulation biobanking is going to face an uphill battle in capturing public trust:STAFF REPORT.doc-Arthur Caplan
Background...Given that human tissue samples are increasingly used in translating biomedical discoveries into improved medical care, the issue of human tissue samples has assumed greater importance at the National Institutes of Health (NIH) and strengthened the need for more guidance to NIH-funded institutions (NIH's extramural research program that more than 80% of NIH's budget) as well as for the Institutes and Centers at the NIH that conduct their own research (NIH's intramural research program). The focus of the hearings is the collection, storage, tracking, and use of human tissue samples in the NIH intramural research program.
The Committee's investigation in this area was prompted in part by concerns raised by Susan Molchan, M.D., Program Director for Alzheimer's Disease Research at the National Institute of Aging (NIA), to Committee staff in April 2005. Dr. Molchan had been a clinical researcher interested in Alzheimer's disease research at the National Institute of Mental Health (NIMH). From 1993 to 1995, she conducted a small clinical trial involving the collection of spinal fluid from about 25 people (some patients with Alzheimer's disease and some normal volunteers) and the use of lithium as a probe for potential biomarkers of Alzheimer's disease in spinal fluid and blood. In early 1997, Dr. Molchan left the NIMH, but she had not finished this study. She had published two papers and used at the very most 20% of the spinal fluid collected. The unused spinal fluid remained stored in freezers at the NIMH Geriatric Psychiatry Branch. The Chief of the Geriatric Psychiatry Branch was Trey Sunderland, M.D., who assumed control of the spinal fluid samples after Dr. Molchan left NIMH. At a hearing on June 22, 2004, the Subcommittee on Oversight and Investigations revealed that Dr. Sunderland had received over $500,000 in payments from Pfizer during 1999-2004 for outside consulting and speaking without any record of prior approval for these activities or disclosure in his government financial- report filings.
In the fall of 2004 Dr. Molchan was now at the NIA and was trying to assist an outside researcher in getting unused samples from Dr. Molchan's study at NIMH. Ultimately by March 2005, Dr. Molchan learned that Dr. Sunderland was only able to produce around 2-3% of unused spinal fluid that remained from the lithium study and that the clinical data from that study had been purged. She was concerned about what happened to the more than 95% of the unused spinal fluid samples left in the freezer and to the data. In particular, after learning from public reports about Dr. Sunderland's undisclosed Pfizer activities, she was concerned that Dr. Sunderland might have inappropriately or improperly diverted spinal fluid samples from her lithium study to Pfizer as part of his financial relationship. She pursued her concerns for several weeks during March-April 2005 through various NIH channels and with the Office of Inspector General (OIG), Department of Health and Human Services (HHS). In April 2005 she contacted staff with the Committee on Energy and Commerce.
In investigating her concerns and in general about the relevant NIH policies, the Committee staff learned from NIH officials that NIH had no uniform, centralized, and mandatory authority regulating the handling of human tissue samples. Some NIH laboratories kept a written record on the maintenance of these samples, but other NIH laboratories did not. Although there were explicit regulations defined in 42 C.F.R. 72.6 detailing the handling for hazardous biological materials and select agents, there was no explicit policy for the handling and accounting of human tissue samples. In addition, there was no formal inventory control or tracking system at NIH. If a freezer or other storage facility malfunctions and the human tissue samples become unusable, NIH laboratories were not required to account for the disposition of these samples. There was reason to believe that there were cases where NIH lost human tissue samples but had no record of what had been lost. Moreover, the lack of accountability left NIH wholly vulnerable to theft and diversion of valuable human tissue samples. These preliminary inquiries raised serious concerns over what was described to Committee staff by NIH officials of a fairly loose, ad-hoc approach to controlling human tissue samples.
On June 20, 2005 the bipartisan leadership of the Full Committee and the Subcommittee sent a letter to the Director of the NIH requesting records and information on how human tissue samples are obtained, stored, tracked, and used in intramural programs throughout the institutes and centers of the NIH. One subject area of the Committee's June 20, 2005 request concerned the disposition of spinal fluid samples from patients with Alzheimer's disease and control subjects collected by scientists at the National Institute of Mental Health (NIMH) to be used in studies involving lithium. After the NIH's August 15, 2005 production, the Committee staff alerted the NIH that it appeared that not all responsive documents concerning these samples and Dr. Molchan's lithium study had been provided to the Committee. After the Committee staff raised these concerns with the NIH about the production, the Committee did receive additional responsive records: three sets of records over the last few months from the NIH related to the spinal fluid samples and the lithium study, with the last set received on January 4, 2006. The Committee was troubled that the NIH did not produce all the responsive records in the first production, and produced these records only after Committee staff pressed several times for these additional responsive records.
Most importantly, an NIH document received by the Committee in early 2006 documented that Dr. Sunderland's branch had sent spinal fluid samples to Pfizer from 538 subjects, who had participated in 14 different studies at NIMH. The protocol numbers listed on the documents showed that spinal fluid had been sent to Pfizer from subjects who had participated in Dr. Molchan's lithium study. That fact had not been previously disclosed to either Dr. Molchan or to the Committee.
On January 24, 2006, the bipartisan leadership of the Committee and the Subcommittee sent a letter to NIH requesting additional records about the disposition of the spinal fluid samples, the nature of NIMH oversight over human samples, and the way NIH/NIMH handled the Committee's request for records relating to the lithium study. In addition, on January 24, 2006, the bipartisan leadership of the Committee and the Subcommittee sent a letter to Pfizer, requesting records that could help determine the relationship, if any, between the disposition of the spinal fluid samples in question and Dr. Sunderland's official and/or private consulting activities with Pfizer.
To review these issues related to human tissue samples, the Committee staff conducted extensive interviews with officials from the NIH, former officials with the NIH, officials with Pfizer, former officials with Pfizer, and other individuals. Staff reviewed documents obtained by the Committee from the NIH and Pfizer. Staff also reviewed public information and records.
After several months of work, the Committee staff wrote a staff report summarizing the findings and supporting evidence. The staff report addressed three questions. In brief, the staff report's findings can be summarized as follows:
Question One: Did Dr. Sunderland obtain personal financial benefits from outside activities (with no record of disclosure to NIH or approval by NIH) with Pfizer, Inc., in any way because of actions he took in his official capacity in facilitating the transfer to Pfizer of human spinal-fluid samples and plasma samples, which were the assets and property of NIH?
Finding/Supporting Evidence: Yes. Records and interviews provide reasonable grounds to believe that Dr. Sunderland personally received $285,000 in compensation from Pfizer for activities that were derived directly from his official acts in providing Pfizer access to spinal fluid samples and plasma samples (over 3000 tubes of NIH property and linked clinical data) and that Dr. Sunderland used NIH employees and resources to provide such access.
Question Two: Does the available evidence provide reasonable grounds to believe that Dr. Sunderland and others omitted important information, or provided inaccurate information, about the circumstances surrounding Dr. Sunderland's collaborations with Pfizer, Inc. that involved the human samples provided by Dr. Sunderland?
Finding/Supporting Evidence: Yes. While Dr. Sunderland refused invitations to be interviewed by the Committee, records and interviews provide reasonable grounds to believe that some of Dr. Sunderland's statements to the investigators from the Office of Management Assessment and communications from Dr. Sunderland's attorney to the NIH were factually inaccurate or incomplete, especially statements relating to the nature of the Pfizer collaborations involving human tissue samples.
Question Three: Did the Committee's investigation of the circumstances surrounding Dr. Sunderland's transfer of human samples to Pfizer identify evidence that raised other compliance issues and policy questions?
Finding/ Supporting Evidence: Yes. The investigation found reasonable grounds to believe there was questionable compliance with human subject protection and NIH technology transfer policies that existed at the time. The evidence also raised regulatory and ethical questions that are pertinent to NIH's consideration of current policy related to human tissue samples.
Detailed discussion of the supporting evidence and issues raised are covered in the staff report.
Polyheme Blood Study: The Chronicle Hosts an Online Discussion
Well I sure hope that The Chronicle of Higher Education has better luck soliciting discussion about the future of the Polyheme artificial blood product trial than I have had so far. In the conversation that AJOB hosted, to which every single PI of every single Polyheme site was invited, only one PI from one site that was not suspending the study showed up for the call - despite the fact that it was billed as an opportunity to think about how to move forward responsibly with community consultation.
And to the best of my knowledge, ours (Albany Med) is the only institution in the entire PolyHeme study to have conducted any effectiveness analysis of our community consultation, an effort that was of as best I can tell of no interest whatsoever to those who have continued the trial in the face of current uncertainties.
Polyheme and ethical issues in emergency research are the subject of the current issue of The American Journal of BIoethics and of a major research effort at AMBI on community consultation for emergency research utilizing Polyheme as a test case. So we'll be there.
Artificial Life: Talking to the People Who Are Building It
Reed Magazine has a great interview with the guys at ProtoLife in Venice who are building what they see as artificial cells. A philosopher and a financial analyst, lead a group that were it not so interesting and productive would seem like a snake oil team.[thanks Art Caplan]
The Rhythms of Nonsense About Ethical Arguments Against the Rhythm Method
BMJ (pointed to us by Jay Hughes) writes that:People opposed to the destruction of human embryos should be as concerned about potential "embryonic deaths" from the practice of the so-called "rhythm method" as they are about the use of emergency contraception or human embryonic stem cell research, according to an article published in the June edition of the Journal of Medical Ethics, the New York Times reports. Luc Bovens, a philosopher at the London School of Economics and Political Science, has said that couples who try to prevent pregnancy by having sexual intercourse only at the end of the woman's most fertile period might be increasing the chances of conceiving an embryo that does not implant or develop in the uterus, the Times reports. The "same logic that turned pro-lifers away from [EC, intrauterine devices] and [birth control] pill usage should make them nervous about the rhythm method," Bovens writes, adding, "Even a policy of condom usage and having an abortion in case of failure would cause less embryonic deaths than the rhythm method."Boom. Boom. Boom.
Rabbis & New York State Health
New York State has reached a compromise with ultra orthothodox Jewish rabbis that will allow the rabbis to continue the practice of metzizah b'peh, in which the mohel, the religious figure who perfoms a circumcision, cleans the wound by sucking the blood and spitting it out. The practice came to the attention of the State after it learned of seven cases of neonatal herpes connected to the ritual. One of the infected children suffered severe brain injury from the virus and another died.According to the article in the Albany Times Union,
The new state guidelines require mohels, or anyone performing metzizah
b'peh, to sanitize their hands like a surgeon, removing all jewelry,
cleaning their nails under running water and washing their hands for up
to six minutes with antimicrobial soap or an alcohol-based hand
scrub.The person performing metzizah b'peh also must clean his mouth
with a sterile alcohol wipe and, no more than five minutes before it,
rinse for at least 30 seconds with a mouthwash that contains 25 percent
alcohol. The circumcised area must be covered with antibiotic ointment
and sterile gauze after the procedure.
New York State's Commissioner of Health and the rabbis are lauding the
policy as one that respects both religious tradition and public health.
I question whether a compromise is appropriate in this circumstance.
Should newborn babies face even the slightest risk of contracting
potentially lethal oral herpes on their newly cut penises? Some
religious traditions should be outlawed; this is one of them.
- Alicia Ouellette
It's Time to Let Gay Men Give Blood
Art Caplan writes on MSNBC:If you are in a car crash or have a C-section and need a blood transfusion, will the hospital be able to supply the blood you need? Maybe not. If you are a hemophiliac, have certain genetic diseases or are a child with an immune disease and use treatments made from blood to survive, can you get the life-saving products you need? Don't count on it.
Yet, despite the fact that there is a simple change in public policy that could help solve these problems, old fears about AIDS are standing in the way.
At different times during the year, blood banks and hospitals find themselves unable to meet the demand for blood. And the shortage is growing worse. Demand for blood continues to skyrocket as more Americans undergo bypass operations, organ transplants, C-sections, hip and joint replacements and other treatments that require the use of blood. And as more and more people live with immune disorders or diseases that hamper their ability to make blood, the demand escalates.
We also need blood for other reasons. Sadly, the reality of terrorism and violence has become all too real in American life. This means that the chance of not having enough blood on hand in a particular city on any given day is a risk that each one of us faces.
So what is one simple way to get more blood? Let gay men donate it.
A primary source of blood donation that is currently not being used are men who have had sexual relations with other men. After the AIDS epidemic exploded in 1985, the Food and Drug Administration banned blood donations from any man who had sex with another man even once since 1977.At one time, that policy made sense. But it no longer does. Testing for HIV and other infectious diseases has improved enormously since 1985. We don’t worry about heterosexuals who engage in risky behavior and might acquire HIV because we know the strict testing of today will screen out their blood if it is infected with the virus. Yet the FDA has not changed its policy about gay men despite the fact that there are people who will die in the United States or have to postpone elective surgery because of periodic shortages of rare blood types and blood products.
Current technology, which screens for the presence of viral DNA, can detect the presence of HIV at the very earliest stages of infection with uncanny accuracy. Admittedly there is a "window period" during which someone can be infected with HIV and not test positive even with the best of tests. But this window can be measured in terms of days not years and certainly not the decades that are currently reflected in the FDA policy.
The policy of forever excluding people who had male-to-male sex at some point during the past 30 years should have been changed a long time ago. The accuracy of the latest technology for screening blood means that there is no reason to exclude anyone as a donor in any risk group for more than a month.
The question now is whether the FDA and Congress will act or simply let old prejudices, biases and fears stand in the way of supplying the nation with more badly needed blood.
The AIDS epidemic has been with us for 25 years. The policy currently governing blood donation in the United States has been with us for 22 years. Given our ability to guarantee an exceedingly safe blood supply, it is time to revisit the policy and accept blood from all Americans willing to donate. Fear and prejudice should not be allowed to kill people.
The Great Mule Cloning
At last the first major achievement of cloning - mules ties for first place in Nevada race. Well, not every scientific advance is earth-shattering I guess. - Art CaplanMayor Bloomberg, Commencement Speaker, Johns Hopkins
Mayor Bloomberg coined a new phrase to describe those whose loves include intelligent design and the denial of climate change:Each one of you has had two important principles deeply embedded in you through your association with this amazing institution: An unwavering allegiance to the power of science and a profound commitment to use that power to help people. And this is a good thing, because now more than ever, these two fundamental concepts are being ignored, or are under attack.
Today, we are seeing hundreds of years of scientific discovery being challenged by people who simply disregard facts that don't happen to agree with their agendas. Some call it 'pseudo-science,' others call it 'faith-based science,' but when you notice where this negligence tends to take place, you might as well call it 'political science.'
You can see 'political science' at work when it comes to global warming. Despite near unanimity in the science community there's now a movement - driven by ideology and short-term economics - to ignore the evidence and discredit the reality of climate change.
You can see 'political science' at work with respect to stem cell research. Despite its potential, the federal government has restricted funding for creating new cell lines - putting the burden of any future research squarely on the shoulders of the private sector. Government's most basic responsibility, however, is the health and welfare of its people, so it has a duty to encourage appropriate scientific investigations that could possibly save the lives of millions.
'Political science' knows no limits. Was there anything more inappropriate than watching political science try to override medical science in the Terry Schiavo case?
And it boggles the mind that nearly two centuries after Darwin, and 80 years after John Scopes was put on trial, this country is still debating the validity of evolution. In Kansas, Mississippi, and elsewhere, school districts are now proposing to teach 'intelligent design' - which is really just creationism by another name - in science classes alongside evolution ... Hopkins' motto is Veritas vos liberabit - 'the truth shall set you free' - not that 'you shall be free to set the truth!' I've always wondered which science those legislators who create their own truths pick when their families need life-saving medical treatment."
San Francisco Chronicle Puts the Focus on David Magnus
In a colorful and smart profile the San Francisco Chronicle puts the focus on the guy who has turned California into a bioethics powerhouse by building, at Stanford University, an amazing program. It is so refreshing to read the Chronicle describe David Magnus as a tireless "dynamo" who will do anything to support his faculty, institution, peers, students, patients - and to see that paper recognize the importance of the results. Magnus has worked tirelessly - without stopping - to build California's first, best, and most creative comprehensive bioethics research and teaching program.
The profile isn't just well-written, it's accurate:
During a recent lecture to a graduate class in genetics at Stanford, Magnus spoke about the ethics of stem cell research: He's a marathon speaker whose mouth seems always to be racing to keep pace with his thoughts; who, when asked a complex question will often grin and eagerly nod his head before the questioner is finished, simply because he knows exactly where the questioner is going and can't wait to respond.California should be one of the leading states in the nation for the study of bioethics. David Magnus is quietly working incredibly hard - every bit as hard as he has worked to build The American Journal of Bioethics - to make that happen. Stanford has risen into the very top eschelon of comprehensive bioethics programs so rapidly under his watch that it is as though a storm blew through the valley - and it will be outstanding whether or not the rest of the state's medical schools recognize the importance of bioethics. So here's to you David from everyone at AJOB. You'd never have praised yourself this way - but it's about time the San Francisco Chronicle did.
Only at the end of the two-hour session does Magnus reveal that he just flew in from Ottawa and barely arrived in time for the lecture. When he apologizes for his flagging energy, saying he's "run out of steam," the effect is comical because no one in the room could possibly think he's anything less than a dynamo.
"David is definitely a workaholic," says Mildred Cho, associate director of the Stanford Center for Biomedical Ethics. "He is helpful to a fault, in that he will run himself to exhaustion in an attempt to help his colleagues."
"If you need him to come to the hospital or to a late-night meeting, he will be there," says Art Caplan, director of the University of Pennsylvania's Center for Bioethics, where Magnus was graduate studies director from 1997 to 2003. "He can process complex information and boil it down in a way that nonspecialists can understand. ... He can also laugh at himself -- he sometimes gets compulsive about trying to do everything all at once."The work is by definition stressful, Caplan says. "Dying babies and people desperate to have babies and balancing the need to work with industry without getting completely co-opted by them -- are full-time headaches. Plus, if you are a public person as David is, you wind up catching a lot of flak from colleagues who don't agree with you, get angry that you get too much attention or are just plain mad about something you said."
Ethics in Emergency Research:
A Special Issue on the Ethics of the Polyheme Artificial Blood Trial
In this month's issue of The American Journal of Bioethics, the AJOB target articles that started and sustained a lengthy debate about the trial of Polyheme, a blood substitute manufactured by Northfield Laboratories. The target articles, quoted in more than 1,400 print newspapers and in thousands of online articles, were also the subject of a special hearing held by Senator Grassley at which the FDA was asked to respond to the target articles. Previously unreleased, however, are the Open Peer Commentaries about the Polyheme articles, which tell an even more in depth story about the arguments for and against this and comparable trials in emergency research, and ultimately point to the incredible importance of community consultation in emergency research, an area that is right at the center of our research at AMBI.
Also in this issue Matt Wynia's column about the market in vaccines, a special Target Article precis of Jon Baron's highly controversial new book Against Bioethics, with commentary from all sides.
Also tons of work is In Focus: Adil Shamoo and David Resnick on risks in phase one trials, Mandy Garber and Bob Arnold on promoting the participation of minorities in research, Jing-Bao Nie on the U.S. coverup of Japanese wartime medical atrocities, and Richard Matthews on the roles of physicians in torture.
